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TESTOSTERONE USE AMONG MENOPAUSAL WOMEN DRAWS FDA ATTENTION

Demand for the hormone is increasing

The use of testosterone by women to treat certain symptoms associated with menopause is drawing increased attention from U.S. health regulators.

The FDA is examining available scientific evidence as off-label use of the hormone grows, particularly for treating low sexual desire associated with menopause.

No product is specifically approved for women in the U.S.

There is currently no testosterone product approved by the FDA specifically for women in the United States.

In practice, some patients receive lower doses of products originally developed for men or use compounded formulations.

What researchers want to understand

Questions being examined include appropriate dosage, potential benefits and possible long-term effects.

Available data on cardiovascular risks and breast cancer remain insufficient to answer all questions surrounding the long-term safety of treatment.

What is already known

Possible effects associated with testosterone treatment include acne and increased hair growth. Voice changes are also among the potential side effects.

The discussion in the United States comes as doctors, researchers and regulators examine how testosterone should be used in women and what additional evidence is needed to determine its long-term safety and benefits.

Source: Reuters and U.S. Food and Drug Administration (FDA)

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